Compounder recall may make drug shortages more severe

The FDA has asked compounding pharmacy Ameridose to recall all of it products after an inspection at the compounding pharmacy raised sterility questions. The agency concedes the move could exacerbate shortages of some drugs.

Ameridose is related by ownership to New England Compounding Center (NECC), the large-scale compounding pharmacy at the center of a fungal meningitis outbreak that has infected more than 375 patients and killed nearly 30 after they were injected for pain with a steroid NECC manufactured. The agency said there have been no reports of infections related to Ameridose products but was taking the precaution out of concern over the company's sterility procedures.The FDA noted Ameridose makes some products that are in short supply and acknowledged the recall could make matters worse but said safety concerns dictated a need for the voluntary recall.

In a release, the agency said the "FDA is working with alternative manufacturers to maintain supplies of these life-saving drugs." Commissioner Margaret Hamburg added "the agency is taking all steps within its authority to help prevent or alleviate shortage situations and to minimize the impact this recall may have on drug supplies."

Some healthcare providers had turned to Ameridose for sodium bicarbonate, Reuters reports, because the drug was already in short supply and they were having trouble finding it. The American Society of Health Systems Pharmacists, on its shortage list, says sodium bicarbonate is used in a number of cases but commonly the injection is "used in critical care settings during advanced cardiac life support (ACLS)."

The drug has been in short supply for several years now after American Regent quit making it and injectable drug leader Hospira ($HSP) ran into manufacturing issues with FDA and halted production to make plant upgrades. Daniel Rosenberg, a Hospira spokesman, said in an emailed statement: "Hospira continues to manufacture sodium bicarbonate and is making progress restoring production to previous levels. We understand the critical market need."

The FDA shortage list indicates that Fresenius Kabi and Amphastar Pharmaceuticals both make the drug, but the list suggests they have been unable to keep up with demand.

The agency was not specific about the sterility issues at Ameridose that it has questioned only that concerns came up as a result of an inspection. An FDA inspection of New England Compounding, which has common ownership, found huge sterility issues. Among the problems noted in a 483 report was the disclosure by an employee that while records indicated it was using sterile APIs, it was not. Some vials of the drug suspected in the outbreak contained a "greenish, black foreign matter," while others contained a "white filamentous material." The company has soiled floor mats an unclean sterilizing machine and is located next to a mattress recycling plant.

While compounding pharmacies generally sell specialized drugs in local markets, Ameridose and New England Compounding Center were both operating on a much larger scale and selling products throughout the country. State authorities generally have oversight over compounders but with the current situation there is a move afoot in Congress to pass a law giving the FDA oversee at least the largest of the compounders.

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